Morbid Obesity Clinical Trial
Official title:
Effect of Continuous Intravenous Lidocaine on Early Rehabilitation in Bariatric Surgery. A Randomized Double Blind Controlled Study
Although peroperative intravenous lidocaine has been shown to be useful in early recovery
after colorectal surgery, its beneficial effect on the specific population of obese patients
scheduled for bariatric surgery remained unknown.
Investigators hypothesized that peroperative intravenous lidocaine could decrease
postoperative opioid consumption and improve postoperative recovery
This is a prospective, double-blind, placebo-controlled, monocentric study. We plan to
recruit 180 obese adult patients scheduled for bariatric surgery in a the french university
hospital of Caen.
Exclusion: contra-indications for any aminoamide local anesthetic (allergy, severe hepatic
disease) and for intravenous lidocaine (porphyria, atrioventricular conduction disturbances,
uncontrolled seizure disease), long term opioid consumption, need for a post-operative
follow-up in an intensive care unit, combined surgical procedure excepting cholecystectomy,
pregnancy.
Patients will be randomly allocated to receive either a saline placebo or lidocaine
continuous infusions during surgery. Morphinic consumption will be assessed from the end of
the procedure until the third day after surgery. Secondary criteria will concern
post-operative recovery, pain and postoperative nausea and vomiting, other medical and
surgical complications, and toxicity. Plasma lidocaine concentrations will be measured in
patients who had received lidocaine in order to determine the safety and efficiency of our
infusion protocol.
Our analysis will be a superiority one, alpha risk is 5% and beta risk is 20%, in intention
to treat, with no intermediate analysis.
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